Glycerin-Preserved, Human-Donor, Corneoscleral Patch Grafts for Glaucoma Drainage Devices

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-22

Study Completion Date

2019-08-31

Brief Summary

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This was a retrospective, non-comparative study of 100 eyes of 100 consecutive glaucoma patients who had undergone glaucoma drainage device implantation (Baerveldt shunt) during January 2006 to December 2016. Glycerin-preserved, human-donor, corneoscleral tissue was used as a patch graft to cover the tube portion of the GDD over the sclera. The patch graft related complication was comparable to the previous reports using conventional sclera or pericardium.

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Detailed Description

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This retrospective, non-comparative study was conducted at the Department of Ophthalmology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand. The medical records of consecutive patients who had undergone glaucoma drainage device implantation employing the fornix-based conjunctival flap technique and using a glycerin-preserved, human-donor, corneoscleral graft. The procedures were carried out by, or under the supervision of, one surgeon (NK) between January 2006 and December 2016 were reviewed. The study protocol was approved by the Siriraj Institutional Review Board, Faculty of Medicine, Siriraj Hospital, Mahidol University.

Conditions

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Glaucoma Graft Failure Intraocular Pressure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Glycerin-preserved, human-donor, cornescleral patch grafts

Consecutive glaucoma patients who had undergone glaucoma drainage device implantation using glycerin-preserved, human-donor, cornescleral patch grafts

glaucoma drainage device implantation

Intervention Type BIOLOGICAL

Glaucoma drainage device implantation, a 350 mm2 Baerveldt (BG 101-350) GDD (Johnson and Johnson, Santa Ana, CA, USA) was performed using glycerin-preserved, human-donor, corneoscleral tissue ( the remaining from a heterologous, human-donor corneal button, obtained from the International Eye Bank of Thailand, after a clear corneal graft had been used for penetrating keratoplasty.) The tissue had been preserved in glycerin using the sterile technique and kept in a medical refrigerator for no longer than 6 months.

Interventions

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glaucoma drainage device implantation

Glaucoma drainage device implantation, a 350 mm2 Baerveldt (BG 101-350) GDD (Johnson and Johnson, Santa Ana, CA, USA) was performed using glycerin-preserved, human-donor, corneoscleral tissue ( the remaining from a heterologous, human-donor corneal button, obtained from the International Eye Bank of Thailand, after a clear corneal graft had been used for penetrating keratoplasty.) The tissue had been preserved in glycerin using the sterile technique and kept in a medical refrigerator for no longer than 6 months.

Intervention Type BIOLOGICAL

Other Intervention Names

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glycerine-preserved corneoscleral patch graft

Eligibility Criteria

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Inclusion Criteria

1. Consecutive patients who had undergone glaucoma drainage device implantations between January 2006 and December 2016 at Siriraj hospital by or under supervision of one surgeon (NK).
2. The GDD implantation using glycerin-preserved, human-donor, corneoscleral tissue as a patch graft